Artis oneFloor-mounted system for uncompromised imaging — Class II medical device recall Z-0614-2018
Terminated recall by Siemens Medical Solutions USA, INC, reported 2018-02-21, distributed in AL, AR, CA, IN, LA, MI, MO, NC…. The possibility exists for the monitor display of Artis one systems with a DP Transceiver below revision 03 to
| Recall number | Z-0614-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Medical Solutions USA, INC, Malvern, PA, United States |
| Recall initiated | 2017-08-22 |
| Classified | 2018-02-14 |
| Reported by FDA | 2018-02-21 |
| Terminated | 2018-08-21 |
| Distributed | AL, AR, CA, IN, LA, MI, MO, NC, NY, PA, TX, WA |
| Serial numbers | 82010, 82038, 82039, 82040, 82044, 82054, 82065, 82066, 82070, 82102, 82105, 82108, 82109 |
Product
Artis oneFloor-mounted system for uncompromised imaging; Artis one, Interventional fluoroscopic x-ray system, Artis one is an angiography system developed for diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. X-ray generator POLYDOROS A100 Plus
Reason for recall
The possibility exists for the monitor display of Artis one systems with a DP Transceiver below revision 03 to experience blinking and/or a blue/black screen
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0614-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.